Methods |
2‐arm controlled randomised trial. |
Participants |
Between February 2005 and March 2005, 130 parturients were randomised in a hospital setting in Tunisia. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients with placenta praevia, antepartum haemorrhage, non‐cephalic presentation, intrauterine death, grand multiparity, (more than 5), fibroids, anticoagulation therapy, previous PPH or previous caesarean. |
Interventions |
5 IU of oxytocin administered by an intravenous bolus (n = 65) versus placebo or control (n = 65). |
Outcomes |
The study recorded the following outcomes: PPH at 1000, transfusion, manual removal of placenta, death, change in Hb level, third‐stage duration (min). |
Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomisation sequence generation was not reported. |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
Unclear risk |
Methods of evaluating blood loss were not reported. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
Intention to treat analysis |
Low risk |
All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised. |
Funding source |
Unclear risk |
Source(s) of funding for the study were unclear. |